Monday, March 27, 2017

FURTHER USABILITY ENGINEERING Q & A

Ques:The first question is
applicability of usability engineering on all products including legacy.
Do we need to go back and remediate all legacy product files that do not have
usability? Is there an expectation to remediate or on a forward moving basis as
we make changes to legacy products.

Ans: I'm not aware of
any expectation on the part of the FDA to require such for legacy products
until they undergo sufficient change(s) to warrant such (which should be
defined in your SOP, as determined by your company's analysis of the usability
issues your products pose; and a discussion / rationale written - almost a memo
to file or "one page" UE File). For CE Marking, you'd have to
talk to your N-B.

Ques: Is the expectation
that all devices go through usability? For example for a simple device like a
syringe where the risk is well understood and low would we conduct usability?
Do you have recommendations for how to proceduralize which products we apply
usability to?

Ans: I would analyze
all, even if only to have a UE File that basically says it's not necessary,
e.g., your example of the syringe. Of course if it has some non-stick
component, then it would probably require such. Your company would have
to make the decisions as to how to proceduralize / decide which to apply UE to.
In my webinar, I basically stated that some products, like needles (not
non-stick), have such a field use history over many decades that they probably
wouldn't need it, but that decision / rationale should be defined by SOP and
recorded per first ans above.

Ques: Annex C of IEC 62366-1 has a statement on
user interface of unknown provenance, can you explain the intent of this? Is
this referring to legacy that does not have usability documentation?

Ans: As discussed in
the webinar, UOUP, applies to user interfaces for which there is no real UE or
similar documentation available from a company / vendor. How it will be
specifically applied I don't yet know -- we'll need some field history.
Pending that, I tend to recommend that it be applied for anything posing
a serious UE issue for which evidence of any HF / UE activity hasn't been
performed / documented. The principle could apply for a company's own
legacy products. Since the analogy to SOUP software was made, how that
principle is implements re: software, might help in defining how to implement
UOUP.

Ques:What class devices does usability apply to?

Ans:
There's no specific reference to class of devices, either US or EU.
Obviously, Class II (and IIa, -b) and III would be more complicated,
higher risk, and more likely to require more HF / UE action -- with new
major changes, or new devices, a written discussion / rationale appropriate to
need / risk, would be appropriate. General controls / cgmps (includes
820.30 where risk mgmt / HF / UE are employed / documented) are also a
requirement for Class I in the US, so address as appropriate, defined by your
SOP.

As mentioned, use the search box in upper right on FDA web site,
as well as links from the above link.

Ques: HE75?

Ans: The ANSI web site sells both HE75 and IEC
62366-1:2015 together, and states:

"The ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor
Set addresses a broad range of human factors engineering (HFE) topics in astructured format. The material
emphasizes adoption of a user-centered focus throughout the product design and
development process, with the goal of making medical devices easier to use and
less prone to use error. By providing a structured approach to user interface
design, this set documents can help manufacturers develop safe and usable
medical devices.

The FDA allows you the manufacturer to determine how to address
(and they allow plenty of leeway as long as the requirements are addressed by
your procedures , and you follow your own procedures). For CE-marking,
work with the preferences of your Notified Body, following
the general outline presented in the webinar / standard (the 9 stages, documented in a Usability Engineering File), and

andwith consideration of the new EU MDR.

I still believe that the new IEC 62366-1:2015 is the documented
process to follow with all current and further UE projects, following and
documenting the 9 stages in the UE File as we discussed in the webinar.
The FDA and ANSI/AAMI HE 75 and others could be used in the actual HF/UE
analysis where appropriate for ideas, but the documented process should follow
IEE 62366-1:2015's 9 stages and the document deliverable in the UE File.

I suspect it will take awhile for some consensus in
implementation to build (with the EU implementation). But I believe that
the "end" result will be similar to what I've outlined above.